The present invention is directed to a self-forming prosthetic device. The present invention is further directed to a method of making the self-forming prosthetic device.
Prosthetic devices are utilized in a variety of applications today. Breast prosthetics are a common type of prosthetic device. Other types of prosthetic devices include stump pads, shoe inserts, and the like. A variety of prosthetic devices have been developed to provide comfort to a patient. These prosthetic devices comprise specific materials and have a specific shape in order to provide a desired feel and comfort level to the patient. However, there continues to be a need for improved prosthetic devices, including stump pads and shoe inserts, which have a desired shape, feel and comfort for patients.
In the event of breast cancer, surgeons often perform mastectomies in order to remove all or part of the cancerous breast. In recent years, surgeons have increasingly utilized partial mastectomies, such as lumpectomies and quadrectomies, when they are sufficient to remove the cancerous tissue from the breast.
In cases involving complete mastectomies, patients can choose from a wide variety of prosthetic devices in order to provide a symmetrical appearance under clothing. Patients who undergo partial mastectomies are presently able to choose a partial prosthesis. Presently, partial breast prostheses are offered in a few different shapes, with each shape being available in a few different sizes. The patient must select an off-the-shelf partial prosthesis having a shape and size that provides the patient with the most symmetry under clothing.
In many cases, the off-the-shelf partial prosthesis have shapes and sizes, which do not provide a good fit with the remaining portion of the patient""s breast. Moreover, occasionally, because of scars or tissue wounds, even patients with full mastectomies can not find prostheses that provide a good fit. Therefore, there exists a need in the art for a prosthetic device that can be custom tailored to the size and shape of the patient""s breast.
In other prosthetic applications, patients have similar difficulties finding an off-the-shelf prosthetic device having the desired shape and size to provide a good fit with the remaining portion of the patient""s body. Because of these and other difficulties associated with current prosthetic devices, there exists a need in the art for a prosthetic device that can be custom tailored to the size and shape of the patient""s body.
The present invention provides a self-forming prosthetic device, which conforms to a portion of a patient""s body, such as a chest wall, a partial breast, a partial leg, a partial foot, or any other part of the body. The prosthetic device is formed from a prosthetic device precursor, which includes at least two separate compartments A and B, wherein compartment A contains a curable material and compartment B contains at least one of a catalyst and a cross-linking agent. In one embodiment, the prosthetic device precursor is formed such that one of compartments A and B comprises a bag, and the other of compartments A and B comprises a capsule within the bag. In a further embodiment, the prosthetic device precursor is formed such that compartments A and B are separate chambers within a bag, separated from one another by an interior film. When the prosthetic device precursor is ready to be fitted, the catalyst or cross-linking agent is mixed with the curable material. The prosthetic device precursor is then placed next to a patient""s body, such as in the patient""s bra, and cures to form a prosthetic device in the shape of the xe2x80x9cmoldxe2x80x9d formed by the patient""s chest wall or breast, and bra.
The present invention is further directed to a method of making a prosthetic device precursor and a self-forming prosthetic device. The method of manufacture enables the production of a prosthetic device, which conforms specifically to a given patient""s body or any other desired shape.
The present invention is also directed to a variety of uses for the self-forming prosthetic device. The various aspects of the present invention may be more clearly understood and appreciated from a review of the following detailed description of the disclosed embodiments.